MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE 1 PC DRAINABLE POUCH WITH SH; POUCH, COLOSTOMY

Model Number 022771

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wheal(s) (2241)

Event Date 07/01/2014

Event Type  Injury  

Event Description

It was reported by the nurse that the end user exhibited moist, cobblestone looking area from 6 to 9 o'clock position that extends out 2 inches from stoma, however the skin is not open.It was further reported the area resembles an orange peel and is bumpy with no drainage.End user currently uses eakin seal, stomahesive paste, stomahesive powder and protective barrier.End user reports going to emergency room and physician recommended surgery.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.

• Brand Name: ACTIVELIFE 1 PC DRAINABLE POUCH WITH SH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4223704
• MDR Text Key: 4973830
• Report Number: 9618003-2014-00094
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PERCOCET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 57